Trial · NCT00955968
IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
NCT00955968, Phase 4, Completed, International Maternal Pediatric Adolescent AIDS Clinical Trials Group; results first posted 2018-02-19
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ConductScience Library. IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women. Trials, record NCT00955968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00955968
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
- NCT number
- NCT00955968
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,653 participants, actual
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Conditions
- HIV Infection
- Interventions
- Highly active antiretroviral therapy (HAART)
- First posted
- 2009-08-10
- Last updated
- 2023-08-14
- Results first posted
- 2018-02-19
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | AIDS defining illness, serious non-AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rate of AIDS - Defining Illness | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | AIDS defining illness, refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | Serious non - AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rate of Deaths | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rate of HIV/AIDS Related Events | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | HIV/AIDS related events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rate of HIV/AIDS Related Events or Death | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | HIV/AIDS related events or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | HIV/AIDS related events or WHO Clinical Stage 2 or 3 events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rate of Grade 2 and Above Toxicity | All laboratory measures were done at entry,4 and 12 weeks after, and then every 3 months until study end. Signs and Symptoms were recorded from study entry to study end. All were followed until July 7, 2015 (an average of 125 weeks of follow-up) | The toxicity events included all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the Division of AIDS (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). The incidence rate was obtained by using the Kaplan-Meier method. |
| Secondary | Incidence Rate of Cardiovascular or Other Metabolic Events | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. |
| Secondary | Incidence Rate of Other Targeted Medical Conditions | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rate of AIDS - Defining Illness | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rate of Deaths | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rate of HIV/AIDS Related Events | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rate of HIV/AIDS Related Events or Death | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rate of Grade 2 and Above Toxicity | All laboratory measures were done at entry,4 and 12 weeks after, and then every 3 months until study end. Signs and Symptoms were recorded from study entry to study end. All were followed until July 7, 2015 (an average of 125 weeks of follow-up) | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rate of Cardiovascular or Other Metabolic Events | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | ||
| SECONDARY | Incidence Rate of Other Targeted Medical Conditions | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group89
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death | Continue HAART | 0.21 | 95% Confidence Interval 0.16 to 0.27 | New cases per 100 person - years | |
| Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death | Stop HAART | 0.31 | 95% Confidence Interval 0.25 to 0.38 | New cases per 100 person - years | |
| Incidence Rate of AIDS - Defining Illness | Continue HAART | 0.10 | 95% Confidence Interval 0.08 to 0.14 | New cases per 100 person - years | |
| Incidence Rate of AIDS - Defining Illness | Stop HAART | 0.15 | 95% Confidence Interval 0.12 to 0.19 | New cases per 100 person - years | |
| Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event | Continue HAART | 0 | 95% Confidence Interval 0 to 0 | New cases per 100 person - years | |
| Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event | Stop HAART | 0 | 95% Confidence Interval 0 to 0 | New cases per 100 person - years | |
| Incidence Rate of Deaths | Continue HAART | 0.10 | 95% Confidence Interval 0.08 to 0.14 | New cases per 100 person - years | |
| Incidence Rate of Deaths | Stop HAART | 0.20 | 95% Confidence Interval 0.17 to 0.25 | New cases per 100 person - years | |
| Incidence Rate of HIV/AIDS Related Events | Continue HAART | 1.32 | 95% Confidence Interval 1.07 to 1.62 | New cases per 100 person - years | |
| Incidence Rate of HIV/AIDS Related Events | Stop HAART | 1.42 | 95% Confidence Interval 1.16 to 1.73 | New cases per 100 person - years |
1 to 10 of 89Source ClinicalTrials.gov
See all 89 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Continue HAART | 828 | |
| Overall Study | STARTED | Stop HAART | 825 | |
| Overall Study | COMPLETED | Continue HAART | 691 | |
| Overall Study | COMPLETED | Stop HAART | 699 | |
| Overall Study | NOT COMPLETED | Continue HAART | 137 | |
| Overall Study | NOT COMPLETED | Stop HAART | 126 |
Source ClinicalTrials.gov
Adverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Continue HAART | 65 | 827 | |
| other | Diarrhoea | Gastrointestinal disorders | Stop HAART | 38 | 825 | |
| other | Nausea | Gastrointestinal disorders | Continue HAART | 54 | 827 | |
| other | Nausea | Gastrointestinal disorders | Stop HAART | 48 | 825 | |
| other | Vomiting | Gastrointestinal disorders | Continue HAART | 46 | 827 | |
| other | Vomiting | Gastrointestinal disorders | Stop HAART | 37 | 825 | |
| other | Acute sinusitis | Infections and infestations | Continue HAART | 31 | 827 | |
| other | Acute sinusitis | Infections and infestations | Stop HAART | 60 | 825 | |
| other | Bacterial vaginosis | Infections and infestations | Continue HAART | 62 | 827 | |
| other | Bacterial vaginosis | Infections and infestations | Stop HAART | 67 | 825 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Continue HAART | 2 | 827 |
| Total, all-cause mortality | Stop HAART | 4 | 825 |
| Total, other adverse events | Continue HAART | 778 | 827 |
| Total, other adverse events | Stop HAART | 765 | 825 |
| Total, serious adverse events | Continue HAART | 10 | 827 |
| Total, serious adverse events | Stop HAART | 3 | 825 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28489856 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AI068632 | International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group | JACKSON, J BROOKS | SOCIAL AND SCIENTIFIC SYSTEMS, INC. | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Continue HAART vs Stop HAART: deaths from any cause | Trial comparisons |
| Continue HAART vs Stop HAART: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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